Who Should AttendThe course is intended for system users, developers, quality assurance, quality auditors and regulatory professionals. It is designed to address their responsibilities, roles, tasks and techniques.

The program will benefit: • System Users • Project Managers • IT Professionals • Regulatory Staff • Quality Assurance and Control Staff • System Developers, Designers and Integrators • System Vendors

DescriptionThis intensive, 2-day course is designed to provide an overview of the various aspects of computer validation including best practices, US and International regulations, and Industry expectations. It addresses the rules, tools and techniques to develop and provide the basis for compliance and implementation for a single system or a company-wide program and process.

The emphasis is on the most recent concepts and practices including: risk assessment, vendor controls, electronic records and signatures, common problems, the Validation Project, Validation Planning, Validation Process, Testing and more. It will answer the key question: “What is enough/When am I done?”

You will have the opportunity to ask specific question and participate in class room exercises as time allows.

Organized by:

CfPA - The Center for Professional Advancement

Invited Speakers:

Philip E. Sax; Chief Regulatory Compliance Officer, Medcomp Inc

Philip E. Sax, Chief Regulatory Compliance Officer, Medcomp Inc, an international medical device company. Mr. Sax is a recognized pioneer and leader in the field of Computer System Validation, having been a founder of Weinberg Spelton and Sax, the first consulting company dedicated to Computer System Validation. Mr. Sax has served on the faculty of Rutgers University, and has lectured at several universities, presented at many industry programs, and has authored several articles on related topics. He has participated in more than 500 related projects.

Mr. Sax has a BA from Rutgers University and a Master of Government Administration from the Wharton School, University of Pennsylvania.